BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTINE RIBBON

    MDR report key: 861525 · Received June 5, 2007

    Report

    Report Number
    3003644133-2007-00003
    Event Type
    Injury
    Date Received
    June 5, 2007
    Date of Event
    March 15, 2007
    Report Date
    April 27, 2007
    Manufacturer
    COAPT SYSTEMS, INC.
    Product Code
    GAN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE INITIAL POST OPERATIVE VISIT, THE PATIENT DID NOT RETURN FOR 18 DAYS DESPITE BEING TOLD TO COME BACK IN A WEEK. AT THE TIME, THE PATIENT RETURNED, AN ABCESS WAS NOTED ON THE LEFT SIDE. THE ABCESS WAS DRAINED AND THE DEVICE TRIMMED. THE PATIENT HAD SEVERAL ADDITIONAL SURGERIES OVER AND OVER THE NEXT TWO TO THREE WEEKS AND WAS PLACED ON ANTIBIOTICS. AT EACH OF THE SURGERIES, INFLAMMATION WAS NOTED, BUT NO SIGNS OF PUS OR INFECTION (NO CULTURES WERE EVER TAKEN). THE DOCTOR HAS REMOVED THE PORTION OF THE DEVICE IN THE AREA OF NOTED PAIN. THE DOCTOR HAS ADMITTED THAT HE APPLIED "TOO MUCH" TENSION DURING PLACEMENT OF THE DEVICE. HOWEVER, HE IS UNCERTAIN AS TO THE DIRECT CAUSE OF THE PAIN. PATIENT HAS BEEN NON COMPLIANT REGARDING DOCTOR PRESCRIPTION OF MEDICATION. THE DOCTOR WILL CONTINUE TO WORK WITH PATIENT TO REDUCE THE PAIN.

    Description of Event or Problem · 1

    DR. USED THE ENDOTINE RIBBON DEVICE IN THE JOWL OF THE PATIENT. TEN (10) DAYS LATER, THE PATIENT RETURNED TO THE DOCTOR AND THE DOCTOR NOTICED A SKIN ABCESS ON THE LEFT SIDE. THE PATIENT REPORTED SORENESS ON RIGHT SIDE, BUT NO SKIN REDNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTINE RIBBON ABSORBABLE SURGICAL SUTURE GAN COAPT SYSTEMS, INC. 13005 01537

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention